Use of virologic assays for detection of human immunodeficiency virus in clinical trials: recommendations of the AIDS Clinical Trials Group Virology Committee

Two specimens obtained at least 72 h apart in the month prior to entry are recommended

S Hammer; C Crumpacker; R D'Aquila; B Jackson; J Lathey; D Livnat; P Reichelderfer

2020

Scholarcy highlights

  • The AIDS Clinical Trials Group offers a unique opportunity for studying the clinical efficacy of therapies targeted at human immunodeficiency virus and AIDSassociated opportunistic infections in a cross-section of medical institutions spread throughout the United States
  • The following is a review of the application of virologic assays used to detect HIV type 1 within the context of multicenter clinical trials conducted by the ACTG
  • It represents the collective effort at standardizing procedures in over 50 U.S virology laboratories that conduct clinical trials sponsored by the Division of AIDS, National Institute of Allergy and Infectious Diseases
  • The assays utilized are, for the most part, based on consensus protocols that were developed by the ACTG virologists and are available in the ACTG Virology Laboratory Manual
  • A sustained 50% fall in immune complex-dissociated p24 antigen concentration is considered a positive response to therapy
  • A quantitative HIV-1 DNA polymerase chain reaction assay is not recommended at this time for use in ACTG protocols
  • Methods are sought to increase ease of use, and to reduce costs, without loss of sensitivity or specificity

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